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- Title
Clinical Trial to Reconfirm the Efficacy and Safety of Cefetamet Pivoxil Treatment in Sinusitis Patients: A Double-Blind, Randomized, Parallel Designed, Multicenter, Active Comparator Study (CASIS Study).
- Authors
Park, Chan-Soon; Cho, Jin Hee; Lee, Heung-Man; Kim, Kyung-Su; Kim, Jin Kook; Kim, Dong-Young; Baek, Byoung Joon; Kim, Hyun Jun; Kim, Yong-Dae; Hwang, Chi Sang; Kim, Seon Tae; Cho, Seok Hyun; Kim, Yong Min; Lee, Seung Hoon; Jeong, Jin Hyeok; In, Seung Min; Kim, Byung Guk
- Abstract
Objective: To evaluate the clinical efficacy and safety of cefetamet pivoxil for the treatment of acute bacterial rhinosinusitis in Korean patients compared to treatment with cefdinir. Methods: A prospective, multicenter, randomized double-blind, comparative study was conducted by the Departments of Otorhinolaryngology–Head and Neck Surgery at 17 hospitals or universities in the Republic of Korea from March 2017 to April 2019. A total of 309 patients were screened and 249 patients participated in the study. Results: Treatment with cefetamet pivoxil for 2 weeks showed 82.4% clinical cure and improvement rates in patients with acute bacterial rhinosinusitis compared to 84.68% in those taking cefdinir for 2 weeks, showing that cefetamet pivoxil administered twice a day for 2 weeks was as effective as cefdinir 3 times a day for 2 weeks for the treatment of acute bacterial rhinosinusitis. The overall adverse reaction rates of both drugs were 10.56% in the cefetamet pivoxil group and 15.49% in the cefdinir group, without serious adverse events or drug reactions. Conclusions: Cefetamet pivoxil twice a day was as efficacious and safe as cefdinir 3 times a day for the treatment of acute bacterial rhinosinusitis, which suggested that cefetamet pivoxil may be a suitable alternative to cefdinir.
- Subjects
SOUTH Korea; DRUG efficacy; RESEARCH; ACADEMIC medical centers; CEPHALOSPORINS; TREATMENT effectiveness; RANDOMIZED controlled trials; COMPARATIVE studies; SINUSITIS; BLIND experiment; RESEARCH funding; BACTERIAL diseases; STATISTICAL sampling; PATIENT safety
- Publication
ENT: Ear, Nose & Throat Journal, 2023, Vol 102, Issue 2, p101
- ISSN
0145-5613
- Publication type
Article
- DOI
10.1177/01455613211036236